Events

Retiro De Equipo (Recall) de Artis zee with sw versions VC21C, VD11 and Megalix Cat+ X-Ray tubes

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-01524-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-21
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01524-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    For artis systems with software versions vc21c, vd11 and megalix cat+ x-ray tubes, the semi-automatic focus switch in cases of a type of defect in foci “small” and “micro” (if present), does not work as intended when pressing the footswitch multiple times. this focus defect, that causes the failure of the semi-automated focus switch, becomes more likely as the service life of the x-ray tube increases.This can result in the spontaneous malfunction of the active (micro or small) focal spot and a loss of imaging. while the manufacturer is not aware of any patient injuries, under the above circumstances this issue can cause a loss of the fluoroscopy functionality and may lead to a situation where the clinical procedure has to be aborted, rescheduled or the patient needs to be relocated to a functioning system.
  • Acción
    A software update will correct the above mentioned issue. After the update, the Artis system will switch again semi-automatically to a functioning focal spot for all focus defects, enabling images to be displayed until the current procedure comes to an end. Users are advised that: - For system operation with a 2-foci Megalix X-Ray tube, it is still possible to perform image acquisition with the large focus after manual selection of a corresponding organ program. - For system operation with a 3-foci Megalix X-Ray tube, fluoroscopy is still possible with the "small" or "micro" focus that is still intact through manual selection of a corresponding fluoro program. In addition, image acquisition with the large focus is still possible. - There should be standard emergency procedures in place in case of system failures.

Device

Artis zee with sw versions VC21C, VD11 and Megalix Cat+ X-Ray tubes
  • Modelo / Serial
    Artis zee with sw versions VC21C, VD11 and Megalix Cat+ X-Ray tubesARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA